LexaGene Holdings Inc (OTCQB:LXXGF) (CVE:LXG) (FRA:5XS2) told investors that it successfully utilized its MiQLab System to detect the presence of a slow-growing bacterium, responsible for millions of dollars of damages to biopharmaceutical manufacturers.
“We are pleased to announce that LexaGene completed a study on C. acnes using the MiQLab System,” VP of Applications and Bioinformatics Nathan Walsh said in a statement. “In this benchmark study, C. acnes was diluted in media down to extremely low levels (below the limit of detection) and cultures were grown for 24 hours to mimic growth in a bioreactor.
“Samples were then collected for MiQLab processing and agar plating, where the plates were incubated under ideal conditions and regularly monitored for signs of countable colonies. Colonies on the plate were not observable until three days after plating. In contrast, the MiQLab successfully detected 100% of the samples in just two hours.”
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Contamination within bioreactors is a common occurrence as it is dependent on mammalian culture, therefore it is critical to keep bioreactors free of unwanted microorganisms.
Vaccines, for example, have to be made from culture free of microorganisms and contaminated batches must be destroyed. Microbial contamination has been responsible for vaccine recalls and vaccine scarcity, highlighting the need for rigorous contamination testing during the manufacturing process, the company said.
“Last fall, a global biopharmaceutical manufacturer contacted LexaGene and purchased a MiQLab System as they wanted to improve their already stringent quality assurance program centered around their bioreactor work,” CEO Jack Regan said.
“This manufacturer continues to regularly use the MiQLab System. As a result of discussions with this customer, LexaGene is working to expand the number of targets included in its bioreactor contamination panel and we expect our efforts supporting this customer and the industry in general will drive additional sales this summer.”
Regan continued: “The biopharmaceutical manufacturing sector is rapidly growing and continues to ramp up to meet global demand for vaccines, monoclonal antibodies, and therapeutic proteins. The MiQLab System, using its fully automated sample preparation and PCR technology, can screen a sample taken from a bioreactor for multiple contaminants that could negatively affect a manufacturing line. In comparison to standard lab-based testing methods, the MiQLab System can return reliable results in a fraction of the time.”
Cutibacterium acnes (C. acnes), a bacterium on human skin is one of the more common contaminants. C. acnes is also one of the hardest microorganisms to detect because it grows very slowly, taking a minimum of three days when starting from ideal laboratory conditions and up to two weeks when starting from a contaminated bioreactor sample. This growing time has a massive negative impact on contract manufacturers and can experiencing lead to expensive losses.
That is why rapid testing, which the MiQLab System provides, is needed during each of the four main phases of manufacturing: the raw materials that go into bioreactors, the seed cultures before transfer to a bioreactor, the small bioreactor material being scaled up to a larger bioreactor, and the final product prior to sending it to the customer.
“In real-world testing, the time benefit of using the MiQLab System over culture may be greater than our laboratory study as it generally takes two full weeks for primary C. acnes cultures to grow from a bioreactor sample,” Walsh said. “Given the MiQLab can detect this bacterium in just two hours, this represents a 168-times improvement in time-to-result. Such a drastic time savings would potentially save manufacturers a significant amount of money as they could more quickly identify contaminated cultures.”
Contact Andrew Kessel at andrew.kessel@proactiveinvestors.com
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